一项意大利、多中心、真实世界、回顾性研究，评估一线帕唑帕尼治疗未经选择的转移性肾细胞癌患者：'Pamerit'研究。

An Italian, multicenter, real-world, retrospective study of first-line pazopanib in unselected metastatic renal-cell carcinoma patients: the 'Pamerit' study.

机构信息

Medical Oncology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.

Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Torino, Italy.

出版信息

Jpn J Clin Oncol. 2021 Mar 3;51(3):484-491. doi: 10.1093/jjco/hyaa193.

DOI:10.1093/jjco/hyaa193

PMID:33212499

Abstract

OBJECTIVE

Despite the current immunotherapy era, VEGFR inhibitors maintain effectiveness in metastatic renal cell cancer. Real-world data concerning pazopanib are limited. The aim of this study is to add information about efficacy and safety of pazopanib as first-line treatment in metastatic renal cell cancer patients not enrolled into clinical trials.

METHODS

Retrospective analysis (the PAMERIT study) of first-line pazopanib in real-world metastatic renal cell cancer patients among 39 Centers in Italy. Outcomes were progression-free survival, overall survival, objective response rate and treatment-related adverse events. Kaplan-Meier curves, log-rank test and multivariable Cox's models were used and adjusted for age, histology, previous renal surgery, International Metastatic RCC Database Consortium score and pazopanib initial dose.

RESULTS

Among 474 patients, 87.3% had clear cell metastatic renal cell cancer histology. Most of them (84.6%) had upfront renal surgery. Median progression-free survival and overall survival were 15.8 and 34.4 months, respectively, significantly correlating with International Metastatic RCC Database Consortium's good prognosis (P < 0.001), ECOG PS 0 (P < 0.001), age (<75 years, P = 0.005), surgery (P < 0.001) and response to pazopanib (P < 0.001). After 3 months of pazopanib, overall disease control rate have been observed in 76.6% patients. Among International Metastatic RCC Database Consortium's favorable group patients, 57/121 (47%) showed complete/partial response. No unexpected AEs emerged.

CONCLUSIONS

In this real-world study, metastatic renal cell cancer patients treated with first-line pazopanib reached greater progression-free survival and overall survival than in pivotal studies and had high response rates when belonging to International Metastatic RCC Database Consortium's favorable group, without new toxicities. Pazopanib has been confirmed a valid first-line option for International Metastatic RCC Database Consortium's good prognosis metastatic renal cell cancer patients who cannot be submitted to immunotherapy.

摘要

目的

尽管目前处于免疫治疗时代，VEGFR 抑制剂在转移性肾细胞癌中仍然有效。关于帕唑帕尼的真实世界数据有限。本研究的目的是提供有关帕唑帕尼作为转移性肾细胞癌患者一线治疗的疗效和安全性的信息，这些患者未入组临床试验。

方法

对意大利 39 个中心的转移性肾细胞癌患者进行帕唑帕尼一线治疗的回顾性分析（PAMERIT 研究）。结果包括无进展生存期、总生存期、客观缓解率和治疗相关不良反应。采用 Kaplan-Meier 曲线、对数秩检验和多变量 Cox 模型，并根据年龄、组织学、既往肾切除术、国际转移性肾细胞癌数据库联盟评分和帕唑帕尼初始剂量进行调整。

结果

在 474 名患者中，87.3%为透明细胞转移性肾细胞癌组织学。他们中的大多数（84.6%）接受了 upfront 肾切除术。中位无进展生存期和总生存期分别为 15.8 和 34.4 个月，与国际转移性肾细胞癌数据库联盟的良好预后显著相关（P<0.001）、ECOG PS 0（P<0.001）、年龄（<75 岁，P=0.005）、手术（P<0.001）和对帕唑帕尼的反应（P<0.001）。帕唑帕尼治疗 3 个月后，76.6%的患者总疾病控制率。在国际转移性肾细胞癌数据库联盟的有利组患者中，57/121（47%）出现完全/部分缓解。未出现新的不良反应。